The aforementioned subsidiary of Huada Gene Holdings is Beijing Huada Jibiai Biotechnology Co., Ltd. (hereinafter referred to as “Beijing Jibiai”), registration certificate of new crown antibody detection kit The number is National Machinery Standard 20203400567, and the validity period is from June 17, 2020 to June 16, 2021.
This product can be used for in vitro qualitative detection of new coronavirus (2019-nCoV) IgM/IgG antibodies in human serum or plasma. It is only used as a supplementary detection indicator for suspected cases with negative detection of novel coronavirus nucleic acid or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as a basis for the diagnosis and exclusion of pneumonia caused by novel coronavirus infection, and is not suitable for general population screening. It is limited to clinical use and emergency reserves during pneumonia outbreaks of new coronavirus infections. It cannot be used as a routine in vitro diagnostic reagent in the clinic and is only used by medical institutions.
New coronavirus detection is an important means of epidemic prevention and control. The new common clinical coronavirus detection reagents include two types: nucleic acid detection reagents and antibody detection reagents. Normally, infections cause the body’s immune system to produce antibodies. At present, nucleic acid detection reagents are mainly used in clinical diagnosis. Antibody detection reagents are only used to supplement the detection indicators for suspected cases with negative nucleic acid detection of new coronavirus or to be used in conjunction with nucleic acid detection in the diagnosis of suspected cases.
Up to now, BGI has three new crown detection kits approved by the State Food and Drug Administration, which are based on the new coronavirus 2019-nCoV nucleic acid detection kit (Joint probe anchored polymer sequencing method), new coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) and new coronavirus (2019-nCoV) IgM/IgG antibody detection kit (enzyme-linked immunoassay).
Before, the new crown antibody detection kit of BGI has completed CE certification and has the access conditions for the EU market.
A variety of nucleic acid detection reagent products of BGI have also obtained overseas certification. In the European market, completed the EU CE certification, and obtainedEuropean Union free sales certificate. In the US market, it has obtained the Emergency Use Authorization (EUA) issued by the US Food and Drug Administration (FDA). In the Japanese market, it has passed the Japanese PMDA certification; in the Australian market, it has obtained the Australian TGA registration. In the Singapore market, it has obtained temporary authorization from the Singapore Health Sciences Board. In the Canadian market, it has passed the certification of Health Canada.
The new coronavirus nucleic acid detection product of its wholly-owned subsidiary BGIEuropeA/S (European Medicine) was also previously included in the World Health Organization (WHO) emergency use list ( “EmergencyUseListing”).
It is worth mentioning that, due to the global demand for new crown epidemic detection kits and other factors, BGI’s operating income in the first quarter of this year was 791 million yuan. A year-on-year increase of 35.78%; net profit attributable to shareholders of listed companies was 140 million yuan, an increase of 42.59% year-on-year. While the performance in the first quarter increased, BGI’s stock price ushered in a continuous rise in the first half of the year, and the stock price has risen more than 100% since this year.